Impact of an additional rupture of the residual membrane on labor timing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores whether a deliberate rupture of the residual membrane affects the latency to labor and the need for induction in women with prelabor rupture of membranes. Eligible participants are adults with a single pregnancy, cephalic presentation, and ruptured membranes but no spontaneous labor within 12 hours. The intervention involves an additional rupture of the residual membrane, with monitoring for labor onset and induction decisions at 24 or 48 hours depending on the center. The goal is to determine if this approach shortens latency to labor without increasing maternal or fetal infection risk. Prior literature on rupture of membranes has focused on frequency and timing of induction, with antibiotic prophylaxis reducing infection risk, and this study aims to address an unanswered question in this area.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women over 18 years of age
* Single foetal pregnancy, cephalic presentation
* diagnosis of membrane rupture with persistence of one membrane and absence of immediate spontaneous labour.
* Person affiliated with or beneficiary of a social security scheme
* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Minor patient
* patient under guardianship/curatorship,
* multiple pregnancy, pregnancy with foetal death
* non-cephalic presentation
* gestational age less than 37 weeks,
* rupture of membranes more than 12 hours ago
* contraindication to vaginal deliver
* meconium-stained amniotic fluid,
* clinical signs suggestive of intrauterine infection (maternal hyperthermia \>38°C, maternal and/or foetal tachycardia, purulent amniotic fluid),
* cervix not accessible for artificial rupture
* vaginismus
* contraindication to a potential expectant management
* indication for induction for another reason

Where it's running

• CHU Angers
  Angers, France Recruiting
• Centre Hospitalier Le Mans
  Le Mans, France Recruiting

Study contacts

• Principal investigator: Marie-Charlotte FAURANT, MD — Centre Hospitalier le Mans
• Study coordinator: Christelle JADEAU
• Email: recherchecliniquepromotion@ch-lemans.fr
• Phone: +33244710204

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.